May 16, 2019
Patent Races: The rush to trademark nature
The race to patent intellectual property is a key mark of any emerging market, with patents widely recognised as the most viable way of securing future earnings and gaining a competitive edge over rivals in the long-term. However, this traditional route of monopolising the market which has characterised the modern history of the pharmaceutical industry may have hit a stumbling block - national protectionism.
Thailand takes on GW Pharma
In Thailand, controversy broke out at the start of the year about a patent claim on certain cannabis extracts by GW Pharmaceuticals and Otsuka Pharmaceutical. The Thai government drug patent department claimed that the Thai Department of Intellectual Property (DIP) ‘rushed’ the inspection of the patent and claims that it is an attempt to copyright a raw extract of cannabis and is not an invention, which is in violation of Thai laws.
To clarify, Article 9(1) of the Thai Intellectual Property Act states that ‘inventions not protected under the Act include microorganisms and/or any part of the microorganisms found in nature, animals, plants and plant extracts.’
The applications made by GW Pharmaceuticals and Otsuka, of which there were several, did include patents for recipes and medicines, including Sativex, the first cannabis-derived prescription drug, which is being used to treat the symptoms of multiple sclerosis. However, several of their applications attempted to patent phytocannabinoids, an active ingredient found naturally.
Several weeks after the story hit the headlines, the application was denied on the grounds that it had attempted to trademark a naturally occurring substance. Critics also claimed that the patent also pre-dated the Thai legalisation of medical cannabis, which would have made it illegal anyway.
In the wake of the incident, commerce minister, Sontirat Sontijirawong reassured the Thai public that “marijuana is Thailand’s future cash crop […] the state is doing its best to protect intellectual rights linked to research into the use of marijuana for medicinal purposes.
India backs patent protections
Laws prohibiting the trademarking of nature are also in place in India and preclude the patentability of plants and animals (except microorganisms) in whole or parts thereof, seeds, varieties, and species. India’s laws also prohibit the trademarking of naturally occurring substances and biological processes.
Although strict laws exist around the use of cannabis in the region, India’s potential cannabis IP is safeguarded by this law to a degree, helping to preserve naturally occurring cannabis or hemp strains should they become heavily commercialised. Other emerging economies in the Asian cannabis market are therefore likely to be taking notes of such legal landmarks in order to ensure their own laws can provide similar protection.
West vs East
On the other side of the Pacific, GW Pharmaceuticals also struggled to secure a patent application in the US, as in January 2019, US Patent #9066920B2 was denied. This patent application by GW Pharmaceuticals, designed to protect the technology around its Epidiolex product was made as follows:
“This invention relates to the use of one or more cannabinoids in the treatment of epilepsy and more particularly to the use of one or a combination of cannabinoids in the treatment of generalized or partial seizure. In one embodiment it relates to the use of the cannabinoid THCV, as a pure or isolated compound, or as a plant extract in which significant amounts of any THC naturally present has been selectively removed. In another embodiment the phytocannabinoid is CBD.”
However, it was deemed that the term ‘use of one or a combination of cannabinoids’ left too much room for GW Pharmaceuticals to use the patent to discourage competition and development.
This represented a major shift in the trend for US cannabis patenting, where cannabis patents have been big business.
The US patent landscape
Despite the fact that the cannabis plant is recognised as being in the public domain, cannabis technology is still patentable.
Indeed the United States Patent and Trademark Office (USPTO) only prohibits patents that encompass human organisms or whose sole purpose is for use in atomic weapons. These regulations mean that new strains of cannabis plants can be patented providing there is evidence of human modification and novel features as a function of genetic engineering or selective breeding – i.e. it hasn’t just been pulled out of a field.
This liberal attitude to patenting has fuelled something of a ‘patent rush’, and the market has subsequently been flooded with new strains and patent claims. But there are now concerns that this massive influx of patents both in the US and globally is restricting innovation, ultimately replacing one form of prohibition with another kind, and as a result, we have seen a decline in US cannabis patents since 2016.
A tightening noose on innovation
Part of the problem relates to the fact that as a relatively new industry, there is a general lack of previous examples and experience in the field. This has resulted in broad utility patents being granted.
However, in August 2018, the US saw the first legal case launched to challenge an overly broad patent. In the case of United Cannabis Corp vs Pure Hemp Collective , US Patent number 9,730,911, the industry is watching and waiting to see whether the case will be thrown out owing to the fact that cannabis is still federally illegal, however, if the case is heard this is likely to start a landslide of legal challenges to invalidate weak cannabis registrations and liberal patents.
A new sequence of events
The recent completion of a comprehensive cannabis reference genome in late January 2019, from Medicinal Genomics, is likely to add fuel to the invalidation fire. The sequencing technology will help to identify patents which have been wrongly given to strains and technology where prior art had already existed. This will involve sequencing cannabis strains cultivated by small-scale breeders that pre-date those which have more recently been granted a patent. If two strains prove to be genetically similar enough then the evidence could be used to overturn patents. The discovery will also give growers and breeders a consistent genome from which to create new strains and the ability to document those changes and therefore protect their work, representing a powerful tool on both sides of the trademarking argument.
Winner takes all?
We appear to be on the brink of a domino chain of global cannabis reform that may set into motion a whole new way of farming and medicating. History tells us that this kind of development will also bring with it a new set of economics and politics and in all likelihood, a new set of winners and losers.
However, laws around the trademarking of nature will likely restore some balance to the market by ensuring that medical cannabis can be better controlled by locals and not just by foreign companies, who have historically used the trademarking system to secure a first-mover advantage, potentially at the expense of further research and development.
We have also moved into an era where nationalism seems to be dominating global politics. Consequently, the pursuit of international trademarking rights is likely to be hotly contested every step of the way.